GUEST COLUMNISTS

• Building Sustainable Biopharma Supply Chains Starts With Procurement

  Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.

• Why You Should Measure Comparability Debt Before Ever Starting A Study

  When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

• What FDA Inspectors Want From Your OOS File

  Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.

• You Can't CAPA What You Can't Classify

  An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

• AI Fills The Decision-Making Gaps In Process Analytical Technology

  When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.

• Is mRNA Manufacturing Overbuilt?

  mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

• CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture

  Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

• Using Digital Platforms To Find Your CDMO

  In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.